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Regulatory Actions for Year 1991

Food and Drug Administration (FDA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Proposed Rule Topical Acne Drug Products for Over-The Counter Human Use; Amendment of Tentative Final Monograph Proposed Rule: Amendment to final monograph for over-the counter topical acne products. This amendment reclassifies the topical acne active ingredient benzoyl peroxide to a "more-data-needed" category.

August 07, 1991 -- 56 FR 37622
Reference to NTP Init-Prom Comparative Mouse Study using different combinations of initiators and promoters including benzoyl peroxide. (TR-441) INIT/PROM